Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma

Melanoma Clinical Trial

Official title:

Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02968680
• Other study ID #: 10M-15-3
• Secondary ID: NCI-2016-0108810
• Status: Terminated
• Phase: Phase 1
• Start date: April 26, 2017
• Est. completion date: January 9, 2020

Study information

• Verified date: March 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.

Description:

PRIMARY OBJECTIVES:

I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.

II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique.

SECONDARY OBJECTIVES:

I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease.

OUTLINE:

Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB).

After completion of study treatment, patients are followed up at 24 and 48 hours.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 9, 2020
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Cutaneous melanoma with Breslow depth > 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression

• Mitotic rate >= 1/mm^2

• Presence of angiolymphatic invasion

• Deep positive margin

• No known allergies to contrast material

Exclusion Criteria:

• Pregnant or nursing

• Patients with known cardiac shunt

• Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification

• Patients who have experienced an acute coronary syndrome or angina in the past 6 months

• Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years

• Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram

• Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram

• Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification

• Patients with hypersensitivity to sonazoid or one of its components

• Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)

• Patients who cannot consent for themselves

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma
• Skin Neoplasms

Intervention

Procedure:
• Sentinel Lymph Node Biopsy
Undergo SLNB

Device:
• Ultrasonography
Undergo sonazoid-enhanced ultrasonography

Drug:
• Sonazoid
Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods	Analyzed using descriptive comparison.	Up to 1 year